Efficacy of Etoricoxib on Peripheral Hyperalgesia

Postherpetic Neuralgia Clinical Trial

Official title:

Efficacy of Etoricoxib in Patients With Neuropathic Pain With and Without Peripheral Hyperalgesia - A Prove of Concept Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01088256
• Other study ID #: Etoricox09-10
• Secondary ID: 2009-015496-27
• Status: Terminated
• Phase: Phase 2
• First received: March 16, 2010
• Last updated: August 23, 2012
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.

Description:

Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years with

• Persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .

• Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS

• One of the two following QST phenotypes at the baseline assessment:

• signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)

• without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)

• Patients of both gender

• Signed consent form

• Patients with the ability to understand and follow the instructions of the doctor

Exclusion Criteria:

• Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.

Excluded will be also all patients with contradictions for the use of Etoricoxib:

• Hypersensitivity to the active substance or to any of the excipients.

• Active peptic ulceration or active gastrointestinal (GI) bleeding.

• Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.

• Pregnancy and lactation

• Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score =10).

• Estimated renal creatinine clearance <30 ml/min.

• Inflammatory bowel disease.

• Congestive heart failure (NYHA II-IV).

• Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled

• Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

• Intake of one of the following drugs (current or in the last 3 days)

• selective-serotonin-reuptake-inhibitor

• cetoconazole

• rifampicin

• phenytoin

• carbamazepine

• dexamethasone or other systemic corticoids

• traditional nonsteroidal antiphlogistics

• cyclooxygenase-inhibitors

• immunosuppressives

• TNF-a-inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Causalgia
• Hyperalgesia
• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Polyneuropathies
• Polyneuropathy
• Postherpetic Neuralgia
• Radiculopathy

Intervention

Drug:
• Etoricoxib
the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
• placebo
patients get one pill of placebo (sugar-pill) per day for 8 days.

Locations

Country	Name	City	State
Germany	Bergmannsheil department of pain therapy	Bochum	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superior improvement of peripheral hyperalgesia at day six after initiation of Cox-2-inhibiting-medication in comparison to placebo		12 month	No
Secondary	Reduction of the average on-going pain	reduction of the average on-going pain decrease of the neuropathic symptoms intensity (NPSI score) decrease of the patients global impression of change (PGIC) decrease of the frequency and cumulative 7 day dosage of rescue medication	12 month	No